Behind the label: Nicorette nicotine patches

We all know that smokers should quit the habit. But does nicotine replacement really help? Pat Thomas investigates

There’s no getting around it. The nicotine in cigarettes is highly addictive and can make stopping smoking a difficult undertaking. Without a regular nicotine fix, smokers can experience withdrawal symptoms such as depression, irritability, insomnia, difficulty in concentrating, restlessness, increased appetite and weight gain that bedevil the job of quitting.

The theory behind nicotine replacement therapy (NRT) – using a nicotine patch, chewing gum or inhaler – is that it provides your body with the nicotine it craves, allowing you to wean yourself off it gradually. Nicotine patches (the most-used method for serious attempts to stop smoking) consist primarily of synthetic rubber into which the nicotine has been dissolved. Body heat encourages the release of the nicotine, through a separate control layer, into the skin. Absorbing the nicotine this way is considered healthier because you do not inhale the upwards of 2,000 other toxic chemicals found in cigarettes.

In 2005 the global NRT market was worth $1.2 billion. In the UK we spend £100 million a year on such products – much of this footed by the taxpayer, via the NHS. Nicorette, manufactured by Pfizer, is the UK’s numberone selling stop-smoking brand, commanding just under half the total market.

The idea of ‘replacement therapy’ suggests that something crucial to health is being replaced. But of course, your body has no biological need for nicotine, and quitting does not produce a deficiency. Instead, NRT is what the late stop-smoking guru Allen Carr called nicotine continuation therapy.

But so powerful is the mythology that says giving nicotine to nicotine addicts helps them quit, that the NHS now supplies NRT free to any smoker who wants to quit. Since 2004, the government, desperate to meet its target to reduce adult smoking rates from 24 to 21 per cent, has been pouring money – around £138 million –into stop-smoking clinics that rely heavily on NRT.

Last year, in a bid to get more smokers to quit, the Committee on Safety of Medicines took the warnings off nicotine patches and other forms of NRT so that pregnant women, breastfeeding mothers and those with liver, heart and kidney disease could have access to them. The NHS also made nicotine patches available to children as young as 12 via their school nurses. As the public and workplace smoking ban comes into place in the UK in July this year, employers are also being encouraged to fund NRT to employees who are smokers, to encourage them to quit.

NRT, it would appear, is helpful for everyone. Yet there are problems with this ‘therapy’ – the most prominent of which are its adverse effects, and the fact that the evidence for its effectiveness, mostly culled from short-term studies, is unconvincing.

Patchy success

Nicotine patches produce their own unique adverse effects, such as skin irritation, which can be minimised with daily rotation of the application site. Sleep disturbance (such as insomnia and nightmares) is also common. Other reported effects of NRT include headache, dizziness, heart palpitations, dyspepsia, nausea, hiccups, muscle pain, anxiety, irritability and poor concentration.

In the UK, clinics using NRT claim that nicotine patches and other forms of NRT help 100,000 smokers a year to quit, but much depends on how you define ‘quitting’. For instance, a 2004 Treasury report into public health spending found that the success rate of NRT had been inflated by broadening the definition of ‘quitting’ to include those who stopped smoking for just two out of the first four weeks of NRT treatment.

In general – and depending on which study you read – six weeks after initiating treatment, 23 to 61 per cent of smokers are successful in ‘quitting’ the habit. Six months down the line this drops to around 20 per cent, while one year on, the success rates range from nine per cent to 28 per cent.

Only one study (published in 2004 in the journal Tobacco Control, part of the British Medical Journal group) has tried to establish how effective NRT is in the longer term. The researchers looked at 12 trials that announced initial results after one year but continued to follow up participants who were deemed to have quit smoking for a longer period, from two to eight years. The analysis showed that three out of 10 people who claimed to have stopped initially using NRT were smoking again after 12 months. After eight years, only 12 per cent of those who had quit using NRT were still non-smokers, compared to eight per cent who used a placebo. The only conclusion that can be drawn from such an analysis is that doing something is better than doing nothing – though clearly not much better.

But I didn’t inhale…

Manufacturers depend on the addictive nature of nicotine to keep customers coming back again and again. Indeed, cigarette manufacturers and NRT manufacturers are now competing for the same market of nicotine addicts. At the moment, NRT manufacturers are on to a winner because of a combination of taxes, smoking bans and free handouts on the NHS.

By the time you read this, the Chancellor, as a public health service, has probably upped the tax on cigarettes again. However, this may simply drive the problem of nicotine addiction underground. For many smokers, using NRT can be cheaper than buying cigarettes. For someone smoking 20 a day, for instance, buying a month’s supply of nicotine patches is a much more cost-effective source of nicotine than buying a month’s supply of cigarettes.

NRT, particularly nicotine gums, which contain 2mg or 4mg nicotine per piece (equivalent to one or two strong cigarettes), is also useful for smokers who have no desire to quit but simply need to be tided over in nonsmoking pubs, restaurants and cinemas until they can find somewhere to smoke again.

The NRT myth may benefit from a lot of glitzy PR and exaggerated success stories. But the figures speak for themselves. In the UK, the number of smokers is decreasing by around 0.4 per cent per year. Contrast this with the 10 per cent a year growth in NRT products. Do the maths. Does NRT really do anything more than keep smokers physically and psychologically addicted to the substance that’s causing their problems in the first place?

Waste management

Most transdermal patches contain 20 times the amount of drug that will be absorbed during the time of application. After removal, most patches contain at least 95 per cent of the total amount of drug initially in the patch. In the USA, nicotine is considered hazardous pharmaceutical waste in the same class as arsenic and cyanide compounds, nitroglycerine and some chemotherapy agents. Yet in that country, as elsewhere in the world, there is no guidance on the environmental impacts of nicotine patches in our waste supply or on how to safely dispose of the millions of used nicotine patches tossed in the rubbish.

Nicotine: Psychoactive drug. Once in the body it causes a rapid release of adrenaline, the ‘fight-or-flight’ hormone that can result in rapid heartbeat, increased blood pressure, rapid, shallow breathing and ultimately, decreased immunity. During pregnancy, nicotine can retard foetal growth. It blocks the release of insulin, resulting in hyperglycemia; it increases the level of low-density liporotein (LDL), the ‘bad’ cholesterol that damages your arteries and increases your risk of heart attack or stroke. It breaks down into various constituents, notably nornicotine, a highly reactive substance implicated in illnesses including cancer, neurological disease such as Alzheimer’s, and cardiovascular disease.

Medium molecular weight polyisobutylene, low molecular weight polyisobutylene: Adhesives, tackifiers. A synthetic rubber with adhesive properties. Nicotine is held in the matrix of the rubber until body heat triggers its release. This rubber can cause allergic/sensitivity reactions. Essentially the same substance used in plastic food wrapping and, as with food wrapping, some of the chemicals present in polyisobutylene may migrate into the skin and thus the bloodstream.

Polybutylene: Plasticiser. Also known as polybutene. Added to the polyisobutylene to make it more permeable, thus allowing the nicotine to migrate in a controlled dose into the skin. Can contain traces of phthalates, which are known carcinogens and reproductive toxins.

Non-woven polyester, backing film: Outer seal. Seals the nicotine into the plastic matrix and provides structure to the patch. Non-woven fabrics are made in part from plastics, which are slow to biodegrade and can contain carcinogens and reproductive toxins.